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市場調査レポート

バイオ医薬品の受託無菌充填・包装:ベストプラクティス

Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2018

発行 HighTech Business Decisions 商品コード 261635
出版日 ページ情報 英文 650 Pages; 175+ Tables & Charts
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.30円で換算しております。
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バイオ医薬品の受託無菌充填・包装:ベストプラクティス Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2018
出版日: 2018年01月31日 ページ情報: 英文 650 Pages; 175+ Tables & Charts
概要

当レポートでは、バイオ医薬品の受託無菌充填・包装の市場を調査し、市場の定義と概要、市場構造と参入事業者、受託業者の無菌充填&包装技術・処理能力・コストの分析、クライアントによるアウトソーシングの見通し、市場規模と市場成長予測、主な受託業者のプロファイルなどをまとめています。

第1章 エグゼクティブサマリー

  • イントロダクション
  • 市場概要
  • 顧客のニーズ:サマリー
  • 受託業者の能力:サマリー
  • 産業動向

第2章 調査方法・定義・略語

第3章 市場概要

  • イントロダクション
  • サプライヤー:受託無菌充填・包装業者
    • 受託業者のタイプ
    • 受託業者
    • 産業の組織的変化
    • 投与形態・サービス
    • CMOの能力
  • 顧客:医薬品・バイオテクノロジー企業
    • 顧客の製品
    • アウトソース業務:投与形態別
    • 顧客による将来のアウトソーシングの見通し
    • 社内能力の拡張
    • アウトソーシングのニーズ
  • 市場能力
  • 市場規模
    • 市場規模推計
    • 市場規模:受託業者収益
    • 市場規模:投与形態・サービスカテゴリー別
  • 市場成長予測
  • 受託製造市場の動向

第4章 医薬品・バイオテクノロジー企業:クライアント分析

  • イントロダクション
  • 製造需要
  • デバイスデリバリー技術
  • 製造技術
  • アウトソーシング戦略
  • 受託業者の選定
  • 受託業者の料金設定
  • アウトソーシングの支出額
  • 受託業者との関係
  • 将来の動向・予測

第5章 受託無菌充填包業者

  • イントロダクション
  • 提供能力
  • 製造の慣習
  • 製造の実践
  • 製造の技術
  • 料金設定
  • カスタマーリレーションズ
  • 産業の成長
  • 課題・将来の動向

付録

目次

This 650-page report, the comprehensive 2018 industry study, provides the latest information on current and future market size, manufacturing technologies and practices, client outsourcing plans, contract outsource capacity, pricing, commercial terms and practices, underserved market needs, and future industry trends in the fill-and-finish contract manufacturing industry. This report highlights both the growth opportunities and challenges facing the contract fill-and-finish industry with respect to aseptic fill. The data and the analysis in this report are based on 38 in-depth interviews with biomanufacturing directors at pharmaceutical and biotechnology companies, and executives from fill-and-finish contract manufacturing organizations worldwide. This report also contains detailed company profiles from 60 fill-and-finish contract manufacturing organizations worldwide, covering information on type of services offered to help with preliminary fill-and-finish CMO research. The analysis of these perspectives provides the readers with insights to understand current and future trends in the biopharmaceutical contract fill-and-finish market, and it equips one with tool to make strategic decisions. This report includes over 175 summary data tables and charts, and is the most comprehensive and current industry report on biopharmaceutical fill-and-finish contract manufacturing.

Table of Contents

Chapter 1: EXECUTIVE SUMMARY

  • 1.1. Introduction
  • 1.2. Market Overview
    • 1.2.1. Introduction
    • 1.2.2. Industry Drivers
    • 1.2.3. Market Size
  • 1.3. Summary of Customer Needs
    • 1.3.1. Products
    • 1.3.2. Outsourcing Strategies
    • 1.3.3. Outsourcing Budgets
  • 1.4. Summary of Fill-and-Finish Contractors' Capabilities
    • 1.4.1. Dosage Forms
    • 1.4.2. Capacity Changes
    • 1.4.3. Industry and Company Growth Rates
    • 1.4.4. Contracting Business by Product Type
  • 1.5. Industry Trends and Observations

Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS

  • 2.1. Research Objectives
  • 2.2. Research Methodology
  • 2.3. Definition of Parenteral Fill-and-Finish Manufacturing
  • 2.4. Box-and-Whiskers Plot Definition
  • 2.5. Acronyms

Chapter 3: FILL-AND-FINISH CONTRACT MANUFACTURING: MARKET OVERVIEW

  • 3.1. Introduction
  • 3.2. Suppliers: The Fill-and-Finish Contract Manufacturers
    • 3.2.1. Types of Fill-and-Finish Contract Companies
    • 3.2.2. Fill-and-Finish Contract Manufacturing Companies
    • 3.2.3. Organizational Changes in the Industry
    • 3.2.4. Dosage Forms and Services
    • 3.2.5. Fill-and-Finish CMOs' Capacities
  • 3.3. The Customers: Pharmaceutical and Biotechnology Companies
    • 3.3.1. Customers' Products
    • 3.3.2. Outsourced Fill-and-Finish by Dosage Form
    • 3.3.3. Customers' Future Outsourcing Expectations
    • 3.3.4. Outsourcing Needs
  • 3.4. Market Capacity
  • 3.5. Market Size
    • 3.5.1. Estimates of Market Size
    • 3.5.2. Market Size by Dosage Form and Service Categories
  • 3.6. Market Growth Forecasts
  • 3.7. Trends in the Fill-and-Finish Contract Manufacturing Market
    • 3.7.1. Industry Challenges
    • 3.7.2. Outsourcing Trend of One-Stop-Shop versus Single-Service CMOs

Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS

  • 4.1. Introduction
    • 4.1.1. Respondent Titles and Locations
    • 4.1.2. In-House Manufacturing Sites
    • 4.1.3. Recombinant Large-Molecule Drug Products on Market
  • 4.2. Manufacturing Demand
    • 4.2.1. Manufacturing Needs
    • 4.2.2. Dosage Forms
    • 4.2.3. Clinical and Commercial Products
  • 4.3. Device Delivery Technologies
    • 4.3.1. Planned Format for Drug Product Launch
    • 4.3.2. Importance of Device Development to Drug Product Portfolio
    • 4.3.3. Container-Closure System Development and Qualification
    • 4.3.4. Formulation Development and Compatibility
  • 4.4. Manufacturing Technologies
    • 4.4.1. Development of Fill-and-Finish Process
    • 4.4.2. New Fill-and-Finish Technologies
    • 4.4.3. Special Handling Requirements
    • 4.4.4. Yield Loss
  • 4.5. Outsourcing Strategies
    • 4.5.1. Current In-House Filling Capacity and Outsourcing Strategy
    • 4.5.2. Changes to In-House Filling Capacity
    • 4.5.3. Fill-and-Finish Importance to Drug Product Portfolio
    • 4.5.4. Focus Areas of Fill-and-Finish Outsourcing Over Next 5 Years
  • 4.6. Outsourcing Needs
    • 4.6.1. Outsourced Services
    • 4.6.2. Areas Underserved by Fill-and-Finish CMOs
    • 4.6.3. Key Challenges a Fill-and-Finish CMO Can Help Alleviate
  • 4.7. Contractor Selection
    • 4.7.1. Preference for Integrated Drug Substance and Drug Product CMO
    • 4.7.2. Top Attributes for CMO Selection
    • 4.7.3. Attributes That Would Prevent CMO Selection
    • 4.7.4. Reasons for Leaving Current CMO
    • 4.7.5. Outsourcing Decision Influenced by CMO Capital Investment
    • 4.7.6. Regional Outsourcing Preference
  • 4.8. Contractor Pricing
    • 4.8.1. Change in CMO Pricing for Fill-and-Finish Services
    • 4.8.2. Price Models Used
  • 4.9. Outsourced Spending
    • 4.9.1. Prices Paid to Fill-and-Finish CMOs
    • 4.9.2. Outsourcing Budget
    • 4.9.3. Outsourcing Budget by Service Category
  • 4.10. Contractor Relationships
    • 4.10.1. Troubleshooting Capabilities of CMOs
    • 4.10.2. Top Issues of Contractors Meeting Expectations
    • 4.10.3. Preferred Contractors
  • 4.11. Future Trends and Expectations
    • 4.11.1. Top Concerns Regarding Contract Fill-and-Finish Industry
    • 4.11.2. Outsourcing Trends for One-Stop-Shop CMOs versus Single-Service CMOs

Chapter 5: FILL-AND-FINISH CONTRACT MANUFACTURERS

  • 5.1. Introduction
    • 5.1.1. Respondents' Titles and Experience
    • 5.1.2. Company Locations
    • 5.1.3. Regulatory Approval Status
    • 5.1.4. Acquisitions and Organizational Changes
  • 5.2. Capacity
    • 5.2.1. Dosage Forms
    • 5.2.2. Current Capacity for Fill-and-Finish
    • 5.2.3. Current Capacity for Lyophilization
    • 5.2.4. Capacity Changes
  • 5.3. Manufacturing Practices
    • 5.3.1. Contracting Business by Product Type
    • 5.3.2. Current and Future Capacity Utilization
    • 5.3.3. Average Batch Size and Batches Ran per Fill Line in 2017
    • 5.3.4. Drug Product Development Support
  • 5.4. Manufacturing Activities
    • 5.4.1. Fill versus Finish Activity Outsourcing
    • 5.4.2. Operational Challenges
    • 5.4.3. Average Yield Loss
  • 5.5. Manufacturing Technologies
    • 5.5.1. Technology Impacts on Operations
    • 5.5.2. Importance of Device Development
    • 5.5.3. Investments in Fill-and-Finish Capabilities Over Next 5 Years
    • 5.5.4. Investments in Specialized Equipment
    • 5.5.5. New Technologies or Capabilities Needed
  • 5.6. Pricing
    • 5.6.1. Change in CMO Pricing for Fill-and-Finish Services
    • 5.6.2. Price Structures for Fill-and-Finish
    • 5.6.3. Batch Pricing
    • 5.6.4. Gross Profit Margin
  • 5.7. Customer Relationships
    • 5.7.1. How CMOs Differentiate Themselves
    • 5.7.2. Structure of Multi-Molecule Agreements
    • 5.7.3. Liability Limits
    • 5.7.4. Liability Limits for High-Cost API
    • 5.7.5. Challenges of Managing Client Relationship
  • 5.8. Fill-and-Finish Industry Growth and Size
    • 5.8.1. Opportunities for Growth in the Fill-and-Finish Industry
    • 5.8.2. Industry and Company Growth Rates
    • 5.8.3. Current and Expected Revenue Categories
    • 5.8.4. Revenues from Clinical Phases
    • 5.8.5. Revenues from Industry Segments
    • 5.8.6. Revenues from World Regions
  • 5.9. Challenges and Future Trends for F&F Manufacturing
    • 5.9.1. Most Significant Challenges/Threats
    • 5.9.2. Outsourcing Trends for One-Stop-Shop CMOs versus Single-Service CMOs

Appendix A: Write-Ups of Interviews with 27 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality

Appendix B: Directory of Biopharmaceutical Fill-and-Finish Contract Manufacturers

Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents

Appendix D: Interview Guide for Biopharmaceutical Fill-and-Finish Contract Manufacturers

LIST OF TABLES

Chapter 1

  • 1.3-1. Respondents' Production Capability by Segment
  • 1.3-2. Gaps and Solutions for In-House Fill-and-Finish Production Capability
  • 1.4-1. Capacity Expansions
  • 1.5-1. Industry Trends and Challenges

Chapter 2

  • 2.2-1. Market Research Steps
  • 2.5-1. Acronyms

Chapter 3

  • 3.2-1. User Respondents' Fill-and-Finish Contract Manufacturers
  • 3.2-2. Examples of Changes or Events in the F&F Industry: Past Two Years
  • 3.2-3. CMO Revenue Mix by Service Category: 2018
  • 3.3-1. Estimates of Needs for Outsourced Volumes for the Respondent Group
  • 3.4-1. Biopharmaceutical F&F Contract Manufacturing Capacity Utilization
  • 3.5-1. Market Size by Dosage Forms in 2017: US$
  • 3.5-2. Market Size by Service Category in 2017: US$

Chapter 4

  • 4.1-1. Titles of Pharmaceutical and Biotechnology Company Respondents
  • 4.1-2. Location of In-House Fill-and-Finish Manufacturing Sites
  • 4.1-3. Number of Recombinant Large-Molecule Drug Products on Market
  • 4.2-1. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Lyophilized)
  • 4.2-2. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Not Lyophilized)
  • 4.2-3. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Lyophilized)
  • 4.2-4. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Not Lyophilized)
  • 4.2-5. Number of Outsourced Products by Phase by Year
  • 4.2-6. Average Outsourcing Percentage by Dosage Form
  • 4.2-7. Number of Biopharmaceutical Products Filled by Dosage Form
  • 4.2-8. Respondents' Biopharmaceutical Product Types by Dosage Form
  • 4.3-1. Device Development Outsourced
  • 4.3-2. Strategies for Qualifying Container-Closure System
  • 4.3-3. Qualifying Container-Closure System
  • 4.3-4. Formulation Development to Ensuring Compatibility
  • 4.3-5. Approaches to Ensuring Compatibility with Fill Process
  • 4.4-1. Approaches to Fill-and-Finish Process Development
  • 4.4-2. Fill-and-Finish Process Development Activities
  • 4.4-3. New Fill-and-Finish Technologies
  • 4.4-4. Causes for Fill-and-Finish Yield Loss
  • 4.5-1. Respondents' Production Capability by Segment
  • 4.5-2. Gaps and Solutions for In-House Fill-and-Finish Production Capability
  • 4.5-3. Core Technology Consideration and Impact on Outsourcing Decision
  • 4.6-1. Outsourcing of Fill-and-Finish Related Services
  • 4.6-2. Number of Products Currently and Planned to Outsource by Service
  • 4.6-3. Areas Underserved by Fill-and-Finish CMOs
  • 4.6-4. Challenges Fill-and-Finish CMOs Can Help Alleviate
  • 4.7-1. Preference for One-Stop-Shop CMO by Company Segment
  • 4.7-2. Top Three Attributes for CMO Selection
  • 4.7-3. Top Three Attributes Prevent CMO Selection
  • 4.7-4. Reasons Why Companies Would Leave Their CMO
  • 4.7-5. Capital Investments That Will Influence Outsourcing Decisions
  • 4.7-6. Regional Outsourcing Preferences
  • 4.7-7. Reasons for Regional Outsourcing Preferences
  • 4.8-1. Price Model Used for Fill-and-Finish Services by Respondent Type
  • 4.9-1. Price Per-Batch by Dosage Form by Product Phase
  • 4.9-2. Examples of Other Services and Material Charges
  • 4.9-3. Fill-and-Finish Outsourcing Budgets by Respondent Type: 2018, 2020, 2023
  • 4.9-4. Simple Average: Percentage of F&F Outsourcing Budget by Service
  • 4.9-5. Weighted Average: Percentage of F&F Outsourcing Budget by Service
  • 4.10-1. Reasons for CMO Troubleshooting Satisfaction Level
  • 4.10-2. Top Issues of Fill-and-Finish Contractors Meeting Expectations
  • 4.10-3. Respondents' Fill-and-Finish Contract Manufacturers
  • 4.11-1. Top Concerns Regarding Contract Fill-and-Finish Industry
  • 4.11-2. Summary of Expected Outsourcing Trends: One-Stop-Shop vs. Single-Service CMO
  • 4.11-3. Summary of Preference for Single-Service CMOs Split by Trend

Chapter 5

  • 5.1-1. Titles of Fill-and-Finish Contractor Respondents
  • 5.1-2. Fill-and-Finish Contractors: Headquarter Locations
  • 5.1-3. Regulatory Agency Approvals
  • 5.1-4. Examples of Company Changes in the F&F Industry: Past Two Years
  • 5.1-5. Organizational Changes Over Last Two Years
  • 5.2-1. Average Batch Size per Fill Line and per Contractor
  • 5.2-2. Fill Capacity by Batch Size at Respondents' Facilities in 2017
  • 5.2-3. Lyophilizer Capacity by Shelf Space at Respondents' Facilities in 2017
  • 5.2-4. Capacity Expansions
  • 5.3-1. Breakout of Contracting Business by Product Type: 2018 and 2020
  • 5.3-2. Average Capacity Utilization Rates
  • 5.3-3. Number of Batches Ran per Fill Line in 2017
  • 5.3-4. Batch Size Ran by Fill Line in 2017
  • 5.3-5. Drug Product Development Support Activities
  • 5.4-1. Limited Finish Capabilities
  • 5.4-2. Operational Challenges
  • 5.4-3. Sources of Product Yield Loss
  • 5.5-1. Technology Impacts on Fill-and-Finish Operations
  • 5.5-2. Investment in Device Development
  • 5.5-3. Fill-and-Finish Investments in Next 5 Years
  • 5.5-4. Specialized Equipment Investments
  • 5.6-1. Pricing Methods for Clinical and Commercial Phase
  • 5.6-2. Gross Profit Margin
  • 5.7-1. Factors CMOs Use to Differentiate Themselves
  • 5.7-2. Multi-Molecule Agreement Value-Adds
  • 5.7-3. Client Relationship Challenges
  • 5.8-1. Opportunities for Growth in the Fill-and-Finish Industry
  • 5.8-2. Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.8-3. Expected Revenue Mix by Service Category: 2018
  • 5.8-4. Expected Revenue Change by Service Category: 2018 to 2020
  • 5.8-5. Expected Revenue by Product Phase: 2018
  • 5.8-6. Expected Revenue Change by Product Phase: 2018 to 2020
  • 5.8-7. Expected Revenue Contribution by Customer Type
  • 5.8-8. Expected Revenue from World Regions
  • 5.9-1. Challenges or Threats to Fill-and-Finish Contract Manufacturing

LIST OF FIGURES

Chapter 1

  • 1.2-A: Size of the Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Market in US$B
  • 1.3-A: Respondents' Biopharmaceutical Products by Phase
  • 1.3-B: Number of Products Outsourced by Dosage Form: 2018-2023
  • 1.3-C: Simple Average Percentages of Expected Overall Outsourcing Budget
  • 1.4-A: Percentage of Fill Lines Among Contractor Respondents for Various Dosage Forms
  • 1.4-B: Capacity Expansion Plans
  • 1.4-C: Annual Growth Rates: Industry Estimate versus Company Forecast
  • 1.4-D: Breakout of Contracting Business by Product Type: 2018 and 2020

Chapter 2

  • 2.4-A: Explanation of Box-and-Whiskers Plot

Chapter 3

  • 3.2-A: Percentage of Fill Lines Available Among Contractor Respondents for Various Dosage Forms
  • 3.3-A: Respondents' Biopharmaceutical Products by Phase
  • 3.3-B: Percentage of Products Outsourced: 2018
  • 3.3-C: Simple Average Percentages of Expected Overall Outsourcing Budget
  • 3.3-D: Number of Products Outsourced by Dosage Form: 2018-2023
  • 3.6-A: Size of the Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Market in US$B
  • 3.7-A: Preference for Single-Service CMOs Split by Trend

Chapter 4

  • 4.1-A: Respondent Locations
  • 4.1-B: In-House Fill-and-Finish Manufacturing Capability
  • 4.2-A: Summation of Outsourced Units Required: Vials
  • 4.2-B: Summation of Outsourced Units Required: Syringes
  • 4.2-C: Percentage of Products Outsourced: 2018
  • 4.2-D: SafeBridge® Category Requirements
  • 4.2-E: Respondents' Biopharmaceutical Products Produced by Dosage Form
  • 4.2-F: Respondents' Biopharmaceutical Products by Phase
  • 4.2-G: Respondents' Biopharmaceutical Products by Company Type
  • 4.3-A: Format Used for Drug Product Launch
  • 4.3-B: Importance of Device Development
  • 4.4-A: Respondents' Special Handling Requirements
  • 4.4-B: Distribution of Percentage of Products with Special Handling Needs
  • 4.4-C: Special Handling Needs Required
  • 4.4-D: Distribution of Average Fill-and-Finish Yield Loss
  • 4.5-A: Distribution of Respondents with In-House Capacity
  • 4.5-B: Changes to In-House Filling Capacity for Respondents with In-House Capability
  • 4.5-C: Fill-and-Finish Importance to Drug Product Portfolio
  • 4.5-D: Outsourcing Focus Areas
  • 4.6-A: Views on Areas Underserved by Fill-and-Finish CMOs
  • 4.7-A: Preference for One-Stop-Shop CMO
  • 4.7-B: Capital Investment's Impact on Outsourcing Decisions
  • 4.8-A: Price Change Over Last Two Years: User Respondents
  • 4.8-B: Different Price Model Used for Commercial Products
  • 4.9-A: Average Per-Batch Price by Product Phase by Product Type
  • 4.9-B: Unit Price versus Batch Size: Non-Lyophilized
  • 4.9-C: Unit Price versus Batch Size: Lyophilized
  • 4.9-D: Price Per-Batch by SafeBridge® Level: Non-Lyophilized
  • 4.9-E: Price Per-Batch by SafeBridge® Level: Small Batch Size
  • 4.9-F: Average Fill-and-Finish Outsourcing Budgets by Respondent Type
  • 4.9-G: Simple Average: Percentage of F&F Outsourcing Budget by Service: 2018
  • 4.9-H: Weighted Average: Percentage of F&F Outsourcing Budget by Service 2018
  • 4.10-A: Satisfaction with CMOs' Troubleshooting Capability
  • 4.11-A: Split Between One-Stop-Shop CMOs versus Single-Service CMOs
  • 4.11-B: Comparison of Outsourcing Trend Segmented by Company Type
  • 4.11-C: Preference for Single-Service CMOs Split by Trend

Chapter 5

  • 5.1-A: Number of Years Fill-and-Finish Services Offered
  • 5.2-A: Percentage of Fill Lines Among Contractor Respondents for Various Dosage Forms
  • 5.2-B: Capacity Expansion Plans
  • 5.3-A: Breakout of Contracting Business by Product Type: 2018 and 2020
  • 5.3-B: Fill Line Capacity Utilization Rates
  • 5.3-C: Lyophilization Capacity Utilization Rates
  • 5.3-D: Average Number of Batches Ran per Fill Line in 2017
  • 5.3-E: Average Batch Size Ran by Fill Line in 2017
  • 5.4-A: Fill versus Finish Capabilities
  • 5.4-B: Average Yield Loss
  • 5.5-A: Importance of Device Development
  • 5.5-B: Fill-and-Finish Investment Areas
  • 5.5-C: Specialized Equipment Investments
  • 5.5-D: New Technologies or Capabilities Needed
  • 5.6-A: Price Change Over Last Two Years: CMO Respondents
  • 5.6-B: Price Change Over Last Two Years: CMO and User Comparison
  • 5.6-C: Pricing Methods
  • 5.6-D: Use of Different Pricing Methods Based on Product Phase
  • 5.6-E: Batch Size
  • 5.6-F: Batch Pricing
  • 5.6-G: Unit Prices versus Batch Size
  • 5.6-H: Average Targeted and Achieved Gross Profit Margins
  • 5.7-A: Multi-Molecule Agreements in Place
  • 5.7-B: Aggregate Liability Limits
  • 5.7-C: Batch Liability Offering for High-Cost API
  • 5.8-A: Average Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.8-B: Expected Service Mix Revenue by Contractor Type: 2018
  • 5.8-C: Expected Revenue by Product Phase: 2018
  • 5.8-D: Expected Revenue Contribution by Customer Type
  • 5.8-E: Expected Percentage of Business from World Regions
  • 5.9-A: Challenges or Threats to Fill-and-Finish Contract Manufacturing
  • 5.9-B: One-Stop-Shop Outsourcing Trends
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